Kornimate/medical-research-clean huggingface dataset:
non-operative management of early appendicitis in children

Conditions: Appendicitis

Summary: the purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. we hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. there have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children. the primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. recurrence is defined as need for appendectomy. the secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.we hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up. this is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). there will be two cohorts; those who agree to receive non-operative management (non-operative group) and those that permit us to track their standard treatment course (surgery group).

Eligibility criteria:
inclusion criteria: * age : 7-17 years * ultrasound (us) or ct scan confirmed early appendicitis (us: hyperemia, \<1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; ct: hyperemia, fat stranding, \<1.1 cm in diameter, no abscess, no fecalith, no phlegmon) * white blood cell count (wbc) \< 15,000 * c reactive protein (crp) \<4 (if obtained) * focal abdominal pain \</= 36 hours prior to receiving antibiotics exclusion criteria: * english is not the primary language of either the child or parent/guardian * other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (bmi ≥ 95th percentile for age and sex), severe developmental delay * positive urine pregnancy test * diffuse peritonitis * fecalith * history of chronic intermittent abdominal pain * wbc \>/= 15 * crp\>/= 4 (if obtained) * pain \> 36 hours prior to first antibiotic dose or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Keywords: appendicitis pediatrics children non-operative
randomized trial on scarpa fascia preservation during hernio-abdominoplasty

Conditions: Ventral Hernia

Summary: this randomized trial aimed to assess the efficacy of preservation of scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.


Eligibility criteria:
inclusion criteria: * patients with complex ventral hernia that are fit for surgery (asa class i and ii) (saklad, 1941). * patients with class iii, iv according to pitanguy's classification of abdominal deformities (pitanguy, 1995). exclusion criteria: 1. patient with asa class iii, iv, and v. 2. morbid obesity (bmi \> 40). 3. recurrent incisional hernias after mesh hernioplasty. 4. strangulated hernias. 5. isolated small paraumbilical hernias. 6. patients with abdominal organomegaly and/or ascites. 7. patients with coagulopathy, 8. patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.
covid-19 patient in reims university hospital in march to april 2020

Conditions: Coronavirus Infections

Summary: medical context: follow-up of a retrospective cohort of 499 cases of covid-19, hospitalized at the university hospital of reims during the health crisis, prospectively up to two years of follow-up. possible intervention for serological monitoring, leading to a change from category 3 to category 2 (french law on human person research) aim of the study: to know the factors of gravity of covid-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients. material and methods: type of study: cohort study population: patients in the covid-19 cohort - reims calendar: september 2020 - july 2022 expected results: better knowledge of the cares of patients with covid-19


Eligibility criteria:
inclusion criteria: * patient hospitalized for covid-19 infection during the health crisis, in a short-stay service of reims university hospital and included in covid-19 cohort * age \> 18 years * patient who benefit from the national health insurance coverage * patient agree for participation (consent form signed) exclusion criteria: * patient protected by law
study comparing esomeprazole and acetylsalicylic acid (asa) combined together as one capsule versus these medications taken separately

Conditions: Peptic Ulcer Disease

Summary: the purpose of this study is to investigate whether treatment with a combination capsule of esomeprazole 40 mg and aspirin (asa) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. two different forms of esomeprazole (tablets and capsules) will be investigated.


Eligibility criteria:
inclusion criteria: * non-smoking male or female within the age range of 20 to 50 years * body mass index (bmi = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2 exclusion criteria: * documented upper gastrointestinal surgery * use of any proton pump inhibitors or any bismuth preparations (e.g. pepto-bismol®) within 14 days preceding the screening visit

Keywords: bioequivalence asa esomeprazole peptic ulcer disease primary cardiovascular protection healthy volunteers
a study of 99m tc pertechnetate produced in high energy cyclotron in patients with thyroid scan indication

Conditions: Autoimmune Thyroid Disease; Congenital Hypothyroidism

Summary: prospective, open label single site study to demonstrate the safety and efficacy of tc-99m pertechnetate produced by high energy cyclotron at chus.

the proposed clinical trial will be a prospective, case-controlled phase i, open label, single site study. the first 10 consecutively enrolled patients will receive cyclotec standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent case-matched controls, will receive gpert and will also have additionnal whole body scan.

Eligibility criteria:
inclusion criteria: * prescribed thyroid scan * provided written informed consent prior to participation * biochemical parameters within 5 times of the normal limits for age * wbc count \> 3.0/μl * anc count 1.5/μl * platelets \> 75,000/μl * haemoglobin \> 10 g/dl * karnofsky performance scale score \> 50 exclusion criteria: * nursing or pregnant females * biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the scan * wbc \< 3.0/μl * anc \< 1.5/μl * platelets \< 75,000/μl * haemoglobin \< 10 g/dl * unable and unwilling to follow instructions and comply with the protocol * unable or unwilling to provide written informed consent prior to participation in the study * karnofsky performance scale score \< 50
prevalence of sleep disturbances in elderly people hospitalized in medicine, psychiatry and rehabilitation departments: topase prospective study, riph 3

Conditions: D012893; Sleep Disorder

Summary: objectives and evaluation criteria: the main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the ght 49 healthcare establishments. the primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the spiegel scale. research plan and procedure: patients participating in the study will be asked to complete a questionnaire including the spiegel scale at two points during their hospitalization: * day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the spiegel scale. * day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the spiegel scale. number of research participants: as the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test. pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week. given the number of beds in the ght 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included. research duration: inclusion period: 5 days, monday to friday participation period: 3 days (from day 0 to day 2) study duration: 7 days


Eligibility criteria:
inclusion criteria: * patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the ght 49 healthcare establishments, * anticipated hospital stay \> 48 hours exclusion criteria: * patient hospitalized for more than 24 hours, * inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.), * no mastery of french * patient hospitalized for sleep pathology (evaluation or treatment), * patient hospitalized in an intensive psychiatric care room, * patients hospitalized under duress, * patient opposition, * patient under guardianship or curatorship.

Keywords: sleep wake disorders sleep elderly hospitalized recovery process rehospitalizations overmedication iatrogenics daytime sleepiness fatigue
correlation of hemodynamics in pulmonary hypertension with perfusion lung scans

Conditions: Pulmonary Arterial Hypertension

Summary: the goal of our study is to correlate data from non-invasive tests such as perfusion lung scans with hemodynamic measurements from right heart catherizations.

data collected from pah patients who have had non-invasive ventilation/perfusion testing, echocardiography, chest ct scan, pulmonary function testing and the correlation of those results to the hemodynamic parameters right heart catherization results and the various biomarkers.

Eligibility criteria:
inclusion criteria: * pulmonary arterial hypertension exclusion criteria: * non-pulmonary arterial hypertension

Keywords: pah; v/q scan;rhc;echo;ct scans; angiography;pfts
fertilizations with immotile sperm: pentoxyphylline activation alone, or with chemical oocyte activation

Conditions: Infertility

Summary: immotile sperm is a rather frequent problem encountered in ivf patients. treatment is usually based on inducing motility with pentoxyphylline (pxn) followed by icsi. however, fertilization rate with this method is still lower compared with icsi using motile sperm. one of the reasons for that is the immotile sperm inability to activate the oocyte our research hypothesis is that better fertilization rate can be accomplished in these cases by combining pxn sperm activation with ca ionophore oocyte activation.


Eligibility criteria:
inclusion criteria: * women up to 35 years of age * immotile sperm * at least 6 mature eggs exclusion criteria: * globozoospermia * "freeze all" cycles because of ohss risk.

Keywords: ivf icsi asthenospermia pentoxyphylline spermatozoa
ultrasonography of the neuromuscular degeneration behavior in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a progressive and fatal neurological disease. an exhaustive and frequent clinical evaluation can lead to establish an adequate and early treatment of the consequences of its evolution. objectives. 1. to evaluate the evolution of diaphragmatic and peripheral neuromuscular degeneration by ultrasound examination in patients with als and to establish possible evolution patterns. 2. to verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used. 3. to compare the ultrasonographic features of subjects with als and a sample of healthy subjects methods. a longitudinal observational study in a consecutive sample of patients diagnosed with als will be realized. all the patients will be examined 3 times, with an interval of at least 3 months between tests. bilateral and cross sectional ultrasonography of several peripheral muscles and diaphragm will be performed at rest and during muscle contraction. all the images will be processed and analyzed for obtaining morphometric variables (muscle thickness) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). frequency of twitches will be also recorded in peripheral muscles.also clinical features will be noted, every time of the 3 exams, from revised amyotrophic lateral sclerosis functional rating scale (alsfrs-r), british medical council research scale(mrc), and routine pulmonary tests.


Eligibility criteria:
inclusion criteria: * definite als exclusion criteria: * primary lateral sclerosis (pls) * other forms of motor neuron disorders
pilot study of a multimodal prehabilitation pancreatic cancer program

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (tnt) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (pdac)

this research study involves an exercise and nutrition program that will consist of twice weekly exercise sessions and discussion with a nutritionist with possible nutrition supplementation. the names of the study interventions involved in this study are: * exercise intervention * nutrition intervention the research study procedures include: screening for eligibility, study evaluations, and follow up visits.

Eligibility criteria:
inclusion criteria * adults age 18 years or older. * diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable pdac as defined by the national comprehensive cancer network (nccn). * planning to undergo tnt at mgh. * planning to receive modified folfirinox for neoadjuvant chemotherapy. * planning to undergo surgical resection of pdac at mgh. * verbal fluency in english. exclusion criteria * metastatic disease. * previous treatment for pancreas adenocarcinoma and no prior therapy for any cancer within 5 years. * known history of cognitive or psychologic impairment. * known history of physical impairment such as immobility, use of walking aids, or required wheelchair use. * known history of the following orthopedic comorbidities: advanced osteoarthritis or rheumatoid arthritis, mobility-limiting amputations, orthopedic injuries, or widespread chronic pain (e.g. fibromyalgia). * known history of the following pulmonary comorbidities: severe chronic obstructive pulmonary disease (copd) defined as fev1 ≤ 50%, emphysema, interstitial lung disease, and/or use of supplemental oxygen. * known history of the following cardiovascular comorbidities: uncontrolled hypertension, severe congestive heart failure (nyha class iv), and/or myocardial infarction within the last 6 months. * inability to tolerate diet through routine oral routes and/or patients with strict nutritional restrictions, allergies, and/or dietary preferences.

Keywords: pancreatic ductal adenocarcinoma total neoadjuvant therapy prehabilitation exercise nutrition optimization surgery
glycemic response to oral nutrition supplements

Conditions: Diabetes

Summary: this will be a randomized, cross-over study of two oral nutrition supplements in individuals with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age 20-75 yrs * type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (amaryl), glipizide (glucotrol/glucotrol xl) and glyburide (diabeta, micronase, glynase prestabs); meglitinides such as reaglinide (prandin) and nateglinide (starlix); and alpha-glucosidase inhibitors such as acarbose (precose) and miglitol (glyset) * hemoglobin a1c less than 9.0% * fasting blood glucose less than 180 mg exclusion criteria: * allergy to milk protein or any other component of the formula
evaluation the impact of subcutaneous irrigation on wound complications

Conditions: Cesarean Section; Complications, Wound, Hematoma

Summary: to evaluate the effect of subcutaneous irrigation on wound complications

cesarean section is the most common abdominal operation performed worldwide. as with every other surgical procedure, it is sometimes accompanied by surgical complications. wound complications are encountered in approximately 5% of women that undergo cs and include haematomas, seromas and infection. to evaluate the effects and benefits of subcutaneous irrigation during cesarean section we decide to conduct this randomized study.

Eligibility criteria:
inclusion criteria: * age 18-40, undergoing cesarean section exclusion criteria: * patients with systemical disease, body mass index\>30

Keywords: wound infection cesarean section
assessing physician and hemophilia a patient reasons and expectations for switching treatment to kovaltry & jivi: a nested study within an existing registry

Conditions: Hemophilia A

Summary: this us study aims to assess hemophilia a patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. for this purpose, this research study will include hemophilia a patients who have switched from an existing therapy to kovaltry or jivi. in doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia a and to more fully understand what drives patient switching from a patient perspective and a physician perspective.

this observational study consists of a patient and a physician survey. this survey will consist of questions developed by bayer and submitted to the steering committee of the existing registry, athn-2. once enrolled to participate in the athn-2 registry and provided consent to participate in the bayer nested study, patients who have switched from another product to kovaltry or jivi within the past 50 weeks or at the time of enrollment will be prompted to answer the additional survey questions. conclusion of the athn-2 registry is scheduled for 2021. once data is cleaned and locked by the registry, the data will be delivered to bayer for conduct of our analyses.

Eligibility criteria:
hemophilia a patients who have switched treatment to treatment with kovaltry or jivi within the past 50 weeks, who are enrolled the athn 2: factor switching study, and who have consented to participate in the kovaltry or jivi specific module will be included in this study.
study evaluating the safety and effectiveness of the flexus(tm) interspinous spacer

Conditions: Lumbar Spinal Stenosis

Summary: the purpose of this investigation is to evaluate the safety and effectiveness of the flexus™ interspinous spacer as compared to the xstop® spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.


Eligibility criteria:
inclusion criteria: * lumbar spinal stenosis as defined by leg, buttock or groin pain, with or without back pain, that relieves during flexion, with radiographic confirmation of spinal stenosis by ct or mri scans at one or two contiguous levels between l1 and s1. if back pain is also present, it must be partially relieved during flexion * narrowing of the spinal canal, nerve root canal or intervertebral foramen at one or two levels * able to sit for 50 minutes without pain * able to walk 50 feet or more * age 50 years or over * has completed at least 6 months of conservative treatment * has a zurich claudication questionnaire (zcq) score of ≥ 1.5 for physical function (pf) and ≥ 1.5 for symptom severity (ss) * other as specified in the approved protocol exclusion criteria: * cannot sit for 50 minutes without pain * cannot walk for more than 50 feet * unremitting pain in any spinal position * axial back pain only without leg, buttock, or groin pain * fixed motor deficit * cauda equine syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retension or incontinence) dysfunction * severe symptomatic lumbar spinal stenosis at more than two levels * significant instability of the lumbar spine * has had any surgery of the lumbar spine * morbid obesity defined as a body mass index \>40 or a weight more than 100 lbs over ideal body weight * active systemic disease such as aids, hiv, hepatitis, etc. * active systemic or local infection * angina, active rheumatoid arthritis, advanced diabetes or any other systemic disease that would affect the subject's welfare or outcome of the study * osteoporosis, defined as dexa bone density measured t-score \< -2.5 * spinal metastasis to the vertebrae * known allergy to device materials titanium, tantalum, or polyetheretherketone (peek) polymer * other as specified in approved protocol

Keywords: back pain pain spinal diseases spinal stenosis lumbar vertebrae spinal canal
effectiveness of ai genetic counseling program vs in-person genetic counseling in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to help better understand the uptake and impact of genetic testing for women diagnosed with breast cancer who do not meet national comprehensive cancer network (nccn) criteria for genetic testing. by doing so, the research team will gain a better understanding of the clinical implications for offering genetic testing for all patients recently diagnosed with breast cancer versus only offering genetic testing to those meeting nccn criteria. by offering genetic counseling and genetic testing to all women recently diagnosed with breast cancer, there will be a shortage of genetic counselors. this study will also assess the feasibility of using artificial intelligence to assist in the genetic counseling process.

this is a randomized trial comparing the effectiveness of pre-test genetic counseling using an artificial intelligence program and traditional in-person genetic counseling in women newly diagnosed with breast cancer who do not currently meet national comprehensive cancer network (nccn) criteria for genetic testing. the primary objectives of this study are: 1. to determine up-take of testing for those who do not meet nccn guidelines for genetic testing 2. to assess overall patient satisfaction and comprehension in both groups the secondary objectives of this study are: 1. to assess mutation rate in the overall cohort 2. identify reasons for not pursuing genetic testing 3. identify any specific areas of improvement in satisfaction and comprehension 4. assess the impact of genetic testing on time to treatment in this cohort 5. develop workflow for offering genetic testing, providing pre-test genetic counseling, ordering testing, and delivering results

Eligibility criteria:
inclusion criteria: * subjects diagnosed with stage 0-3 breast cancer. * patients who do not satisfy current nccn criteria for referral to a genetics counselor and genetics testing. * must have the ability to understand and the willingness to sign a written informed consent document as well as complete the study questionnaires. exclusion criteria: - n/a